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This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYS6051 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYS6051 | Drug | SYS6051 is administered by intravenous infusion every 3 weeks (Q3W). The doses administered for the first and subsequent visits of SYS6051 will be calculated based on the weight at screening/baseline and prior to dosing at subsequent visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | From Day 1 to Day 21 | |
| Frequency and severity of AE | From Day 1 to 30 days after last dose. | |
| Maximal tolerable dose (MTD) | From Day 1 to 12 months. | |
| Recommended phase 2 dose (RP2D) | From Day 1 to 12 months. | |
| ORR | From Day 1 to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | From Day 1 to 12 months. | |
| AUCss, | From Day 1 to 12 months. | |
| ORR |
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Inclusion Criteria:
Exclusion Criteria:
1. Presence of high bleeding risk factors; 2. Presence of active ocular disease; 3. Patients with other active malignant tumors; 4. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose; 5. Serious chronic or active infection; 6. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study; 7. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis; 8. History of non-infectious lung disease/pneumonitis requiring steroid hormone therapy or current interstitial lung disease/pneumonitis or suspected by imaging during screening; 9. History of significant cardiovascular disease; 10. History of immunodeficiency, Active hepatitis B or hepatitis C; 11. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation; 12. Pregnant or lactating women; 13. Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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This is the first-in-human phase I study of SYS6051 and this study consists of two part: a dose escalation and backfill part and a cohort expansion part.
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| From Day 1 to 12 months. |
| PFS | From Day 1 to 12 months. |
| OS | From Day 1 to 18 months. |
| Positive rate for ADA | From Day 1 to 18 months. |